Product Code: NBC
FDA class 2
21 CFR 862.1117
Test, Natriuretic Peptide
Clinical Chemistry
The Natriuretic Peptide Test is a clinical chemistry in vitro diagnostic device used to measure natriuretic peptides (such as BNP or NT-proBNP) in blood, which are biomarkers of cardiac stress and are used to diagnose and monitor heart failure, guide therapy, and assess prognosis in cardiac patients. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 862.1117 (Clinical Chemistry specialty).
510(k)s
45
FEI Numbers
37
Registration Numbers
37
Unique Applicants
18
Years Active
25
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Basic Information
- Product Code
- NBC
- Device Class
- FDA class 2
- Regulation Number
- 862.1117
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 45 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252169 | Access BNP II | Mar 24, 2026 | Substantially Equivalent | Beckman Coulter, Inc. |
| K253539 | Alere NT-proBNP for Alinity i | Feb 18, 2026 | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. |
| K241176 | Alere NT-proBNP for Alinity i Reagent Kit | Jan 16, 2025 | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. |
| K232164 | Access NT-proBNP | Apr 12, 2024 | Substantially Equivalent | Beckman Coulter, Inc. |
| K220265 | ADVIA Centaur® NT-proBNPII (PBNPII) | Sep 24, 2023 | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. |
| K223637 | Elecsys proBNP II, Elecsys proBNP II STAT | Jul 21, 2023 | Substantially Equivalent | Roche Diagnostics |
| K210546 | Elecsys proBNP II, Elecsys proBNP II STAT | Mar 31, 2022 | Substantially Equivalent | Roche Diagnostics |
| K211199 | ST AIA-PACK BNP Assay | Nov 08, 2021 | Substantially Equivalent | Tosoh Bioscience, Inc. |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | Oct 04, 2021 | Substantially Equivalent | Ortho Clinical Diagnostics |
| K192380 | ST AIA-PACK BNP | Aug 24, 2020 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K092649 | ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 | Feb 04, 2010 | Substantially Equivalent | Roche Diagnostics Corp. |
| K082645 | DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 | Sep 22, 2008 | Substantially Equivalent | Siemens Healthcare Diagnostics |
| K063662 | RAMP NT-PROBNP ASSAY | Jul 21, 2008 | Substantially Equivalent | Response Biomedical Corp. |
| K080269 | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS | Jun 06, 2008 | Substantially Equivalent | Biosite Incorporated |
| K080578 | DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA | May 16, 2008 | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. |
| K073091 | VIDAS NT-PROBNP ASSAY, MODEL: 30 449 | Feb 29, 2008 | Substantially Equivalent | bioMerieux, Inc. |
| K072437 | ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET | Feb 05, 2008 | Substantially Equivalent | Roche Diagnostics |
| K072189 | PATHFAST NTPROBNP AND D-DIMER TESTS | Feb 05, 2008 | Substantially Equivalent | Mitsubishi Kagaku Iatron |
| K071834 | STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM | Aug 17, 2007 | Substantially Equivalent | Dade Behring, Inc. |
| K071767 | DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A | Aug 04, 2007 | Substantially Equivalent | Dade Behring, Inc. |
| K061795 | DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR | Sep 11, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K053597 | I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) | Jul 21, 2006 | Substantially Equivalent | I-Stat Corporation |
| K060632 | VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158 | Jun 06, 2006 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K060964 | ARCHITECT BNP ASSAY, MODEL 8K28 | May 25, 2006 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K051596 | STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204 | Mar 13, 2006 | Substantially Equivalent | Nanogen, Inc. |
| K052789 | TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 | Jan 23, 2006 | Substantially Equivalent | Biosite Incorporated |
| K051382 | ELECSYS PROBNP IMMUNOASSAY | Dec 05, 2005 | Substantially Equivalent | Roche Diagnostics Corp. |
| K051787 | TRIAGE BNP TEST, MODEL 98000XR | Sep 22, 2005 | Substantially Equivalent | Biosite Incorporated |
| K051265 | ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY | Jun 13, 2005 | Substantially Equivalent | Bayer Healthcare, LLC |
| K043228 | ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS | Apr 22, 2005 | Substantially Equivalent | Bayer Healthcare, LLC |
| K043476 | STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT | Feb 15, 2005 | Substantially Equivalent | Dade Behring, Inc. |
| K042347 | MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD | Nov 19, 2004 | Substantially Equivalent | Dade Behring, Inc. |
| K041417 | DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423 | Jul 20, 2004 | Substantially Equivalent | Dade Behring, Inc. |
| K040425 | ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS | Jun 14, 2004 | Substantially Equivalent | Bayer Healthcare, LLC |
| K033606 | ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST | Jan 30, 2004 | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. |
| K032235 | MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST | Jan 28, 2004 | Substantially Equivalent | Biosite Incorporated |
| K033383 | TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 | Dec 23, 2003 | Substantially Equivalent | Biosite Incorporated |
| K032646 | ELECSYS PROBNP IMMUNOASSAY | Nov 12, 2003 | Substantially Equivalent | Roche Diagnostics Corp. |
| K032525 | BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER | Sep 09, 2003 | Substantially Equivalent | Bayer Healthcare, LLC |
| K031038 | ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY | Jun 23, 2003 | Substantially Equivalent | Bayer Healthcare, LLC |
| K030286 | TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL | Feb 21, 2003 | Substantially Equivalent | Biosite Incorporated |
| K022516 | ELECSYS PROBNP IMMUNOASSAY | Nov 19, 2002 | Substantially Equivalent | Roche Diagnostics Corp. |
| K021317 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST | Jul 01, 2002 | Substantially Equivalent | Biosite Incorporated |
| K010266 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 | Mar 16, 2001 | Substantially Equivalent | Biosite Incorporated |
| DEN000010 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST | Nov 20, 2000 | Unknown | Biosite Incorporated |
FEI Numbers
This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.